Regulatory Approval Archives

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Funding
- Axial3D secures $18m in equity funding
  
  Funding December 20, 2024
  
  Precision Neuroscience raises $102M to support BCI
  
  Funding December 19, 2024
  
  Flow Medical secures $2m to advance breakthrough thrombolysis catheter for pulmonary embolism treatment
  
  Funding December 18, 2024
  
  Fluid Biomed raises $27m to advance ReSolv brain aneurysm stent
  
  Funding December 17, 2024
Clinical Trials
- SamanTree Medical’s Histolog scanner shows promise in breast surgery outcomes
  
  Clinical Trials December 16, 2024
  
  Protaryx Medical completes first-in-human trial of transseptal puncture device
  
  Clinical Trials December 12, 2024
  
  EndoQuest wins FDA IDE to study surgical robot in colorectal surgery
  
  Clinical Trials December 11, 2024
  
  ShiraTronics initiates FDA IDE study for implantable neuromod
  
  Clinical Trials December 6, 2024
Innovation
- Verathon launches sustainable single-use laryngoscope
  
  Innovation November 29, 2024
  
  VUZE Medical demonstrates new multi-tool 3D guidance in spine surgery
  
  Innovation November 28, 2024
  
  Globus Medical launches ExcelsiusHub navigation system
  
  Innovation November 27, 2024
  
  Vascular stent graft maker Solaris Endovascular launches to address vascular health challenges
  
  Innovation November 14, 2024
Regulatory Approvals
- FDA grants IDE approval for the pivotal trial of Roivios’ JuxtaFlow® renal assist device
  
  Regulatory Approvals December 20, 2024
  
  Onward wins FDA De Novo classification for non-invasive spinal cord stimulation system
  
  Regulatory Approvals December 20, 2024
  
  HeartBeam’s arrhythmia assessment system gains FDA 510(k) clearance
  
  Regulatory Approvals December 18, 2024
  
  Cercare Medical secures FDA clearance for CT Perfusion Imaging software
  
  Regulatory Approvals December 17, 2024
Mergers & Acquisitions
- DHG boost market-leading pressure ulcer prevention portfolio with Sumed acquisition
  
  Mergers & Acquisitions October 18, 2024
  
  Wellvii, B-Secur partner to integrate ECG into at-home monitoring tech
  
  Mergers & Acquisitions October 4, 2024
  
  Flat Medical acquires InjeQ’s IQ-Tip needle system
  
  Mergers & Acquisitions September 30, 2024
  
  Vitalograph acquires respiratory diagnostics company Morgan Scientific
  
  Mergers & Acquisitions September 25, 2024
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Axial3D secures $18m in equity funding

Precision Neuroscience raises $102M to support BCI

Flow Medical secures $2m to advance breakthrough thrombolysis catheter for pulmonary embolism treatment

Fluid Biomed raises $27m to advance ReSolv brain aneurysm stent

SamanTree Medical’s Histolog scanner shows promise in breast surgery outcomes

Protaryx Medical completes first-in-human trial of transseptal puncture device

EndoQuest wins FDA IDE to study surgical robot in colorectal surgery

ShiraTronics initiates FDA IDE study for implantable neuromod

Verathon launches sustainable single-use laryngoscope

VUZE Medical demonstrates new multi-tool 3D guidance in spine surgery

Globus Medical launches ExcelsiusHub navigation system

Vascular stent graft maker Solaris Endovascular launches to address vascular health challenges

FDA grants IDE approval for the pivotal trial of Roivios’ JuxtaFlow® renal assist device

Onward wins FDA De Novo classification for non-invasive spinal cord stimulation system

HeartBeam’s arrhythmia assessment system gains FDA 510(k) clearance

Cercare Medical secures FDA clearance for CT Perfusion Imaging software

DHG boost market-leading pressure ulcer prevention portfolio with Sumed acquisition

Wellvii, B-Secur partner to integrate ECG into at-home monitoring tech

Flat Medical acquires InjeQ’s IQ-Tip needle system

Vitalograph acquires respiratory diagnostics company Morgan Scientific

Tag: Regulatory Approval

Beyond Air’s LungFit PH system gains European CE mark approval

Neo Medical’s spine care platform fully approved under EU Medical Device...

PixCell Medical gains EU IVDR certification for complete blood count analyser

Geistlich Pharma and StimLabs partner for wound care distribution in US

Distalmotion gains FDA De Novo approval for its Dexter surgical robot

LifeSignals gains FDA approval for UbiqVue wearable biosensor

CorVent wins FDA clearance for Respond critical care ventilator

FDA clears SonoMotion’s Stone Clear device to treat kidney stone fragments

Augmedics picks up FDA nod for new CT-Fluoro registration

BrightHeart earns FDA clearance for AI-powered prenatal heart ultrasound tech

FDA grants IDE approval for the pivotal trial of Roivios’ JuxtaFlow® renal assist device

Axial3D secures $18m in equity funding

Onward wins FDA De Novo classification for non-invasive spinal cord stimulation system

Precision Neuroscience raises $102M to support BCI

Guided Solutions Appoints Marco Müller as New Managing Director Germany to Drive Strategic Growth

Guided Solutions Appoints Manu Chhokra as Managing Director for Switzerland

FDA clears portable blood, IV fluid warmer from Mequ

Editors’ Choice: Q1 2024 in MedTech